A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
This trial is active, not recruiting.
|Conditions||ovarian neoplasms, brca1 protein, brca2 protein|
|Treatment||ku-0059436 (azd2281)(parp inhibitor)|
|Start date||July 2005|
|End date||December 2008|
|Trial size||95 participants|
|Trial identifier||NCT00516373, D0810C00002, KU36-92|
To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Brussels, Belgium||Research Site||no longer recruiting|
|Amsterdam, Netherlands||Research Site||no longer recruiting|
|Szczecin, Poland||Research Site||no longer recruiting|
|Edinburgh, United Kingdom||Research Site||no longer recruiting|
|London, United Kingdom||Research Site||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
KU-0059436 administered orally twice daily
To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436
time frame: assessed at each visit
Objective tumour response
time frame: assessed every 8 weeks
Male or female participants from 18 years up to 130 years old.
- Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.
- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).
|Official title||A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.|
|Principal investigator||Dr. Johann De Bono, PhD MRCP FRCR|
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